WEBCOL

Description of Event or Problem

THE CUSTOMER REPORTED THAT SHE PURCHASED OUR PRODUCT THAT IS RECALLED. SHE HAS STOPPED USING THEM. SHE STATED THAT SHE HAD A REACTION A COUPLE OF TIMES WHEN SHE SELF-INJECTED DIABETES MEDICATION THAT WAS NOT NORMAL. SHE GOT INFLAMED AND ITCHY WITH RED SPLOTCHES. SHE HAS SINCE STOPPED USING THE PRODUCT. PER THE INITIAL REPORTER ON 05MAY2026, SHE THREW THE PRODUCT OUT ONCE SHE SAW THE NOTICE SO SHE DOES NOT HAVE THE LOT NUMBER OR SAMPLES. SHE SAID SHE DID NOT REQUIRE ANY MEDICAL INTERVENTION BEYOND NEOSPORIN AND CORTISONE, WHICH SHE HAD ON HAND.

Additional Manufacturer Narrative

A DEVICE HISTORY RECORD REVIEW COULD NOT BE CONDUCTED BECAUSE A LOT NUMBER WAS NOT PROVIDED. THEREFORE, A REVIEW OF THE SPECIFIC MANUFACTURING AND INSPECTION RECORDS WAS NOT POSSIBLE. HOWEVER, ALL PRODUCT LOTS ARE REQUIRED TO MEET ESTABLISHED ACCEPTANCE CRITERIA AND MUST SUCCESSFULLY PASS DEFINED VISUAL AND FUNCTIONAL INSPECTIONS PRIOR TO RELEASE. THERE WERE NO DEVICES OR PHOTOS RETURNED FOR EVALUATION; THEREFORE, THE AFFECTED DEVICE COULD NOT BE EVALUATED, AND A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. HOWEVER, A CORRECTIVE AND PREVENTIVE ACTION HAS BEEN INITIATED TO FURTHER INVESTIGATE THE REPORTED ISSUE. WE WILL CONTINUE TO MONITOR AND TAKE ADDITIONAL ACTIONS, AS APPLICABLE.